EXPLANATORY STATEMENT
National Health Act 1953
NATIONAL HEALTH (CONTINUED DISPENSING – EMERGENCY MEASURES) AMENDMENT DETERMINATION 2021 (No. 9)
PB 100 of 2021
Purpose
The purpose of this legislative instrument, made under subsection 89A(3) of the National Health Act 1953 (the Act), is to amend the National Health (Continued Dispensing – Emergency Measures) Determination 2020 to make changes to the pharmaceutical benefits eligible to be provided as a Continued Dispensing supply.
The National Health (Continued Dispensing – Emergency Measures) Determination 2020 (the Principal Instrument) expands the list of pharmaceutical benefits that can be supplied by an approved pharmacist under Part VII of the Act without a prescription, and provides the conditions for such a supply (a ‘Continued Dispensing’ supply).
The amendments made by this instrument reflect amendments to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012), which commence on the same day. The National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012) is made under sections 84AF, 84AK, 85, 85A, 88 and 101 of the Act.
Authority
Subsection 89A(3) of the National Health Act 1953 (the Act) provides that the Minister may determine the pharmaceutical benefits that can be supplied by an approved pharmacist under Part VII of the Act without a prescription, and the conditions for such a supply (‘Continued Dispensing’).
This instrument does not override state and territory poisons laws. States and territories have been informed of the intended Commonwealth changes and asked to consider amendments that may be required to their law to allow access to the eligible medicines.
Amendments made by this Instrument
Schedule 1 to this instrument provides for the addition of the listed drugs brolucizumab, and ofatumumab and for the addition of forms of the listed drugs ciclosporin, nitrofurantoin, and teriparatide to the list of pharmaceutical benefits that may be supplied as a Continued Dispensing supply. It also provides for the alteration of forms of the listed drug sunitinib, deletion of the listed drugs nedocromil, nilutamide and rituximab and for the deletion of forms of the listed drugs sertraline, and terbutaline. These changes are summarised, by subject matter, in the Attachment.
Consultation
This instrument affects approved pharmacists, at or from premises in respect of which the pharmacist is for the time being approved, supplying a pharmaceutical benefit. Consultation was undertaken prior to commencement of the Principal Instrument with relevant peak bodies including the Pharmaceutical Society of Australia and the Pharmacy Guild of Australia. The Department has also undertaken direct consultation with Services Australia and has consulted with state and territory Departments of Health about implementation.
It was considered that further consultation for this instrument was unnecessary due to the nature of the consultation that had already taken place.
General
A provision-by-provision description of this instrument is contained in the Attachment.
This instrument commences on 1 October 2021.
This instrument is a legislative instrument for the purposes of the Legislation Act 2003.
ATTACHMENT
PROVISION-BY-PROVISION DESCRIPTION OF National Health (Continued Dispensing – Emergency Measures) AMENDMENT Determination 2021 (No. 9)
Section 1 Name
This section provides that the Instrument is the National Health (Continued Dispensing – Emergency Measures) Amendment Determination 2021 (No. 9) and may also be cited as PB 100 of 2021.
Section 2 Commencement
This section provides that the Instrument commences on 1 October 2021.
Section 3 Authority
This section states that this Instrument is made under subsection 89A(3) of the of the National Health Act 1953.
Section 4 Schedules
Section 4 provides that each instrument that is specified in a Schedule to the Instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to the Instrument has effect according to its terms.
Schedule 1 Amendments
The amendments in Schedule 1 involve the addition and deletion of listed drugs, and the addition, deletion, and alteration of forms of listed drugs for the list of pharmaceutical benefits that can be supplied as a Continued Dispensing supply. These changes are summarised below.
SUMMARY OF CHANGES TO THE CONTINUED DISPENSING – EMERGENCY MEASURE MADE BY THIS INSTRUMENT
Listed Drugs Added
Listed Drug |
Brolucizumab |
Ofatumumab |
Listed Drugs Deleted
Listed Drug |
Nedocromil |
Nilutamide |
Rituximab |
Forms Added
Listed Drug | Form |
Ciclosporin | Eye drops 1 mg per mL, single dose units 0.3 mL, 30 |
Nitrofurantoin | Capsule 50 mg, USP |
Teriparatide | Injection 250 micrograms per mL, 2.4 mL in multi-dose pre-filled cartridge |
Forms Deleted
Listed Drug | Form |
Sertraline | Tablet 50 mg (as hydrochloride) (USP) |
| Tablet 100 mg (as hydrochloride) (USP) |
Terbutaline | Powder for oral inhalation in breath actuated device containing terbutaline sulfate 500 micrograms per dose, 100 doses |
Alteration of Forms
Listed Drug | Form | |
From: | To: | |
Sunitinib | Capsule 12.5 mg (as malate) | Capsule 12.5 mg |
| Capsule 25 mg (as malate) | Capsule 25 mg |
| Capsule 37.5 mg (as malate) | Capsule 37.5 mg |
| Capsule 50 mg (as malate) | Capsule 50 mg |
Statement of Compatibility with Human Rights
Prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011
National Health (Continued Dispensing – Emergency Measures) Amendment Determination 2021 (No. 9)
(PB 100 of 2021)
This legislative instrument is compatible with the human rights and freedoms recognised or declared in the international instruments listed in section 3 of the Human Rights (Parliamentary Scrutiny) Act 2011.
Overview of the Legislative Instrument
The National Health (Continued Dispensing – Emergency Measures) Amendment Determination 2021 (No. 9) amends the National Health (Continued Dispensing – Emergency Measures) Determination 2020 which specifies the pharmaceutical benefits that can be supplied by an approved pharmacist under Part VII of the National Health Act 1953 without a prescription, and the conditions for such a supply (‘Continued Dispensing’).
The amendments in Schedule 1 involve the addition and deletion of listed drugs, and the addition, deletion, and alteration of forms of listed drugs for the list of pharmaceutical benefits that can be supplied as a Continued Dispensing supply.
Human rights implications
This legislative instrument engages Articles 2 and 12 of the International Covenant on Economic, Social and Cultural Rights (ICESCR) by assisting with the progressive realisation by all appropriate means of the right of everyone to the enjoyment of the highest attainable standard of physical and mental health.
The Pharmaceutical Benefits Scheme (PBS) is a benefit scheme which assists with advancement of this human right by providing for subsidised access by patients to medicines. The recommendatory role of the Pharmaceutical Benefits Advisory Committee (PBAC) ensures that decisions about subsidised access to medicines on the PBS are evidence-based.
Conclusion
This legislative instrument is compatible with human rights because it advances the protection of human rights.
Nikolai Tsyganov
Assistant Secretary (Acting)
Pricing and PBS Policy Branch
Technology Assessment and Access Division
Department of Health